1ST276-100 LuMon™ Belt Size 35

GUDID EIT11ST2761000

SenTec AG

Thoracic electrical impedance system, tomographic
Primary Device IDEIT11ST2761000
NIH Device Record Key9f63c587-17a4-4b57-b068-985235968e2f
Commercial Distribution StatusIn Commercial Distribution
Brand Name1ST276-100 LuMon™ Belt Size 35
Version Model Number1ST276-100
Company DUNS480797856
Company NameSenTec AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEIT11ST2761000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEBVentilatory Electrical Impedance Tomograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-16
Device Publish Date2025-09-08

Devices Manufactured by SenTec AG

07640121881053 - 103583 LuMon™ Contact Gel Kit2025-09-16
EIT11ST1201000 - 1ST120-100 LuMon™ Connector 2.0 2025-09-16 The LuMon Connector 2.0 is a reusable adapter intended to link a LuMon™ Belt to the LuMon™ Monitor.
EIT11ST2721000 - 1ST272-100 LuMon™ Belt Size 192025-09-16
EIT11ST2731000 - 1ST273-100 LuMon™ Belt Size 222025-09-16
EIT11ST2741000 - 1ST274-100 LuMon™ Belt Size 262025-09-16
EIT11ST2751000 - 1ST275-100 LuMon™ Belt Size 302025-09-16
EIT11ST2761000 - 1ST276-100 LuMon™ Belt Size 352025-09-16
EIT11ST2761000 - 1ST276-100 LuMon™ Belt Size 352025-09-16
EIT11ST2771000 - 1ST277-100 LuMon™ Belt Size 402025-09-16

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